(34 days)
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
The Signostics Ltd SpecT system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, on an off-the-shelf display. Automated bladder volume measurements are supported.
The provided text lacks specific "acceptance criteria" in a table format and a detailed study proving the device meets these criteria in the way typically expected for a detailed clinical study with human readers and AI assistance. However, it does contain information related to the device's substantial equivalence to predicate devices based on non-clinical performance data, bench testing, and comparisons of intended use.
Based on the provided text, here's an attempt to extract and infer the closest information to your request:
Key Takeaway from the Document:
The document is a 510(k) premarket notification letter from the FDA, stating that the SpeqT device is substantially equivalent to legally marketed predicate devices. The "study" proving this largely relies on bench testing, compliance with standards, and comparison of technical specifications and intended uses rather than a multi-reader, multi-case clinical study for AI validation. The device is a diagnostic ultrasound system, not an AI-powered diagnostic tool requiring the specific AI-related criteria you've outlined. The "acceptance criteria" are implied by the performance of the predicate devices and the compliance with relevant medical device standards.
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Basis)
The document doesn't explicitly define "acceptance criteria" with numerical thresholds in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is gauged by comparison and compliance with standards.
Table 1: Inferred "Acceptance Criteria" and Reported Device Performance
| Category / "Acceptance Criteria" (Inferred) | Reported Device Performance and Basis for Claim |
|---|---|
| 1. Imaging Performance (General Ultrasound): Substantially equivalent B-mode imaging performance to predicate general ultrasound systems (SpeqRT, Speq, Philips Lumify). | "The new SpeqT has been bench tested for imaging performance and measurement accuracy, with tests showing the SpeqT imaging performance and measurement accuracy to be substantially equivalent to the SpeqRT and Speq predicate devices." (Page 9) |
| 2. Bladder Volume Measurement Accuracy: Performance in automatic bladder volume measurement equivalent or better than predicate bladder scanner (Verathon BVI 9400). | "The second part of the intended use statement [bladder volume measurement] is substantially equivalent to the Verathon BVI 9400 system, and internal clinical performance testing comparing the SpeqT and Verathon BVI 9400 shows the SpeqT to be equivalent or better performance than the Verathon BVI 9400." (Page 8) |
| 3. Acoustic Output: Maintain MI and TI |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.